Mednet, a medical technology service provider and supplier, complements its portfolio of non-sterile CE-marked components with a range of medical high pressure lines and pressure monitoring lines to meet the special needs of kit packers and simplify regulatory operations is expanding. Challenges.
For kit packers, non-sterile CE-marked lines aim to provide two benefits:
(1) Kit packers benefit from the fact that CE marking of lines does not require conformity assessment in terms of entirety. Technical documentation is also the responsibility of the component supplier.
(2) Non-sterile components eliminate the need for time-consuming re-packaging of any sterile alternatives. In addition, the non-sterile components allow for single-use sterilization, thereby avoiding regulatory and qualitative risks. Last but not least, kit packers benefit from the lower cost of non-sterile products compared to sterile components.
Mednet Managing Director Ole Steen said: “Our CE-marked non-sterile components save kit packers a lot of regulatory effort, time and cost.”
High pressure lines (1200 psi) have been developed specifically for cardiology and radiology requirements and are used, for example, for the passage of contrast media and sodium chloride solutions. They are made from DEHP-free PVC or, alternatively, fabric-reinforced PUR and are equipped with a female Luer Lock connector and optionally, a male Luer Lock connector or a swivel adapter.
Pressure monitoring lines (500 psi) can be used for magnetic resonance imaging (MRI), computed tomography (CT) and phlebograph applications, for example, for injection of contrast media or sodium chloride solution. They also provide pressure measurement and are made from DEHP-free, transparent PVC. Lines are equipped with female and male luer lock connectors. Variants with two male connectors are also available as an option.
All high pressure and pressure monitoring lines are available in lengths from 15 cm to 250 cm and are supplied with end caps.
In addition to high pressure lines and pressure monitoring lines, Mednet offers a wide range of other non-sterile CE-marked components (such as introducers, syringes, needles, valves and valve banks).










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